510(k) K233597

Sonosite LX Ultrasound System by FUJIFILM Sonosite, Inc. — Product Code IYN

K233597 is an FDA 510(k) premarket notification submitted by FUJIFILM Sonosite, Inc. for the device "Sonosite LX Ultrasound System". The FDA issued a decision of Substantially Equivalent on Dec 6, 2023. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. FUJIFILM Sonosite, Inc. has at least 10 other 510(k) clearances on record.